Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction (NCT04243265) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction
Italy17 participantsStarted 2015-12-17
Plain-language summary
The objective of the present study will be to evaluate the clinical patellofemoral joint function (primary endpoint) and radiographically the patellofemoral arthritic degeneration (secondary endpoint) of of MPFL reconstruction with fascia lata allograft at a minimum follow-up of 2, 5 and 10 years in a group of 25 patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The potential person is of legal age, capable of providing informed consent and must sign the Informed Consent Form approved by the Ethics Committee (EC).
* Diagnosis of MPFL injury, performed before surgery, documented by Magnetic Resonance Imaging (MRI) of the affected knee.
* Absence of osteochondral lesions larger than 3 cm2 at the baseline.
* The contralateral knee was and is asymptomatic, stable and functional.
* The patient must be physically and mentally inclined and must have completed post-operative rehabilitation according to the protocol provided at the time of discharge.
Exclusion Criteria:
* Local or systemic infection
* Knee osteoarthritis documented radiographically at baseline
* Articular cartilage injury greater than grade I of Outerbridge detected during surgery.
* History of anaphylactic reaction.
* Systemic therapy with all types of corticosteroids or immunosuppressants in the 30 days prior to surgery.
* Evidence of osteonecrosis in the involved knee.
* History of rheumatoid arthritis, inflammatory arthritis or autoimmune pathologies.
* Neurological pathologies or conditions that the patient is unsuitable for the rehabilitation protocol.
* Untreated meniscal tissue loss greater than 50% at baseline.
* State of pregnancy.
* Obese or with body mass index BMI\> 30 kg / m2.
* Association of Trocleoplasty (intervention that produces degenerative changes in the joint in high apercent).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analogue Scale
Timeframe: 120 months
2
Short-Form 12
Timeframe: 120 months
3
Kujala knee Score
Timeframe: 120 months
4
Level of Tegner activity
Timeframe: 120 months
5
Objective evaluation of the International Knee Documentation Committee